NCT03686397已完成3 期
A Phase III, Multicenter, Randomized, Double-Blind Clinical Trial to Assess the Efficacy and Safety of SVT-15652 Otic Solution Compared to Placebo for the Treatment of Fungal Otitis Externa (Otomycosis).
Salvat1 个研究点 分布在 1 个国家目标入组 194 人开始时间: 2020年6月9日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 194
- 试验地点
- 1
- 主要终点
- Therapeutic Cure (Clinical and Mycological Cure)
研究概览
简要总结
Multicenter, randomized, 2-arm parallel-group, double blind, placebo-controlled study in patients suffering from Otomycosis. This study will compare the efficacy and safety of SVT-15652 otic solution to that of Placebo, when administering one vial twice daily during 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least 18 years of age
- •Clinical diagnosis of otomycosis in one or both ears, where topical treatment is indicated.
- •Signs/symptoms of pruritus, otalgia and ear fullness.
- •Debris or drainage clinically consistent with fungal infection.
排除标准
- •Known bacterial otitis externa or malignant otitis externa.
- •Tympanic perforation, tympanostomy tubes inserted and post mastoid surgery.
- •Structural ear anomalies which may difficult the evaluation of the therapeutic response.
- •Uncontrolled diabetes mellitus.
- •Any infection requiring systemic antimicrobial or systemic antifungal therapy.
- •Concomitant medicines that may interfere with the study evaluations.
研究组 & 干预措施
SVT-15652
Experimental
1 vial twice daily
干预措施: SVT-15652 (Drug)
Placebo
Placebo Comparator
1 vial twice daily
干预措施: Placebo (Drug)
结局指标
主要结局
Therapeutic Cure (Clinical and Mycological Cure)
时间窗: Test of cure on day 24
Percentage of subjects with therapeutic cure
次要结局
未报告次要终点
研究者
研究点 (1)
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